This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices,

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
Overview of Device Regulation - FDA
Boston, MA
June 22nd & 23rd, 2017
8:30 AM to 5:30 PM
Thomas E. Colonna
Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
Dr. Thomas E. Colonna earned a bachelor of science
in microbiology from the University of Sciences in Philadelphia (formerly
the Philadelphia College of Pharmacy and Science), a Ph.D. in
molecular biology from the Johns Hopkins University, and a law degree
from the Georgetown University Law Center. In addition to his
consulting activities, Dr. Colonna is the Director of the MS in Regulatory
Science and MS in Food Safety Regulation programs at Johns Hopkins
University.
Dr. Colonna provides consulting services in the scientific and regulatory
aspects of a wide range of medical devices and biologics with particular
expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based,
SNPs, microarrays, and pharmacogenomics), medical device software
(including bioinformatics), and biotechnology-based products.
This course provides a basic description of an FDA regulatory strategy
for medical devices and explains the relationships between regulatory
strategy and product development. It offers guidelines for developing
successful strategies for medical devices, including definitions and
classifications, elements of regulatory strategy, sources of regulatory
intelligence, selection of development and product clearance/approval
pathways.
$6,475.00
Price: $3,885.00 You Save: $2,590.0 (40%)*
Register for 5 attendees
Founder, Biotech Consultant LLC

2. Global
CompliancePanel
Agenda:
Day One Day Two
2-day In-person Seminar:
Overview of Device Regulation - FDA
Lecture 1: Overview of FDA Medical
Device Regulation 9 am - 10.30 am
Registration & Breakfast 8.30 am - 9.00 am
Lecture 2: Overview of FDA Medical
Device 510(k) Premarket
Notification Process
11.00 am - 12.30pm
Break 10.30am - 11.00 am
Lecture 3: Overview of FDA Medical
Device PreMarket Application
Process
1.30 pm - 3.00 pm
Lunch 12.30 pm - 1.30 pm
Lecture 4: Overview of FDA Device
Manufacturing Issues 3.30 pm - 5.00 pm
Break 3.00 pm - 3.30 pm
Lecture 5: Q & A 5.00 pm - 5.30 pm
Lecture 1: Overview of In Vitro
Diagnostic Regulation 9 am - 10.30 am
Registration & Breakfast 8.30 am - 9.00 am
Lecture 2: Overview of Biomedical
Software Regulation 11.00 am - 12.30pm
Break 10.30am - 11.00 am
Lecture 3: Overview of FDA Medical
Device Post-Market
Surveillance
1.30 pm - 3.00 pm
Lunch 12.30 pm - 1.30 pm
Lecture 4: Overview of Device
Regulatory Strategies 3.30 pm - 5.00 pm
Break 3.00 pm - 3.30 pm
Lecture 5: Q & A 5.00 pm - 5.30 pm
Why should you attend:
This course provides a basic description of an FDA
regulatory strategy for medical devices and
explains the relationships between regulatory
strategy and product development. It offers
guidelines for developing successful strategies for
medical devices, including definitions and
classifications, elements of regulatory strategy,
sources of regulatory intelligence, selection of
development and product clearance/approval
pathways.
Who Will Benefit:
 Regulatory professionals working in the medical
device field
Areas Covered in the Session:
 Describe the elements impacting the definition
and classification of medical devices
 Determine the points to consider in the
development of a regulatory strategy
 Define the tools for regulatory strategy
development
 Recognize sources of regulatory and competitive
intelligence
 Identify the elements of a regulatory plan
 Apply regulatory principles to develop a regulatory
plan

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CompliancePanel
www.globalcompliancepanel.com
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Look forward to meeting you at the seminar
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What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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2-day In-person Seminar:
Overview of Device Regulation - FDA